Type 2 Diabetic Patients Maintained on Statin Therapy
Primary Purpose
Dyslipidemia Associated With Type II Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin 40 Mg Oral Tablet
Rosuvastatin 10 Mg Oral Tablet
Sponsored by
About this trial
This is an interventional prevention trial for Dyslipidemia Associated With Type II Diabetes Mellitus focused on measuring Adiponectin, Sortilin, Leptin, Dyslipidemia, Diabetes type II, Rosuvastatin, Atorvastatin
Eligibility Criteria
Inclusion Criteria:
- type II diabetic patients with hypercholesterolemia
Exclusion Criteria:
- liver impairment,
- renal insufficiency,
- coronary artery disease,
- metabolic disorders,
- type I diabetes,
- autoimmune diseases, cancer, infection,
- use of anti-inflammatory drugs,
- recent major surgery,
- weight-loss or modified anti-hypertensive medications 12 weeks or less prior to enrolment,
- ongoing or previous use of lipid-lowering medications (including other statins, fibric acid derivatives, nicotinic acid, cholestyramine, ezetimibe or omega-3 fatty acids) and contraindications to the use of statins.
Sites / Locations
- Tanta University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Atrovastatin
Rosuvastatin
Arm Description
atorvastatin (40 mg per day) for 6 months
Rosuvastatin (10 mg per day) for 6 months
Outcomes
Primary Outcome Measures
hs-CRP (pg/mL)
biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.
sortilin (ng/mL)
Serum Level
adiponectin (ng/mL)
Serum Level
leptin (ng/mL)
Serum Level
Secondary Outcome Measures
glucose level
fasting blood glucose (FBG) (mg/mL)
glycated hemoglobin
glycated hemoglobin (Hb A1c%)
total cholesterol
TCH: total cholesterol (mg/dL)
low density lipoprotein-cholesterol
LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).
high density lipoprotein-cholesterol
HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).
Triglycerides
Triglycerides (mg/dL).
Full Information
NCT ID
NCT03784703
First Posted
December 13, 2018
Last Updated
December 30, 2020
Sponsor
Damanhour University
Collaborators
Tanta University
1. Study Identification
Unique Protocol Identification Number
NCT03784703
Brief Title
Type 2 Diabetic Patients Maintained on Statin Therapy
Official Title
Efficacy of Atorvastatin Versus Rosuvastatin on LV Function and Inflammatory Biomarkers in Type 2 Diabetic Patients With Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Damanhour University
Collaborators
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with diabetes mellitus (DM) are at increased risk of atherosclerotic cardiovascular disease (ACVD). The achievement of the LDL-C target with statins for the reduction of ACVD risk is recommended. However, the risk is still present. Therefore, we investigated the impact of high sensitivity C-reactive protein (hsCRP), sortilin, adiponectin and leptin biomarkers that linking inflammatory hypothesis of diabetes mellitus and atherosclerosis in diabetic patients treated with rosuvastatin and atrovastatin. Methods: Based on exclusion criteria, 150 type 2 diabetic patients were eligible and randomly assigned to receive either 40 mg per day atorvastatin (ATROVA group, n= 80) or 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months.
Detailed Description
a prospective, double blind trial, conducted between January 2018 and January 2020. Participants were enrolled if they had moderate cardiovascular risk (Framingham risk score of 10-20%), in other words 2 or more major risk factors for coronary artery disease (CAD), and LDL-cholesterol level ≥100 mg/dl. All patients gave informed consent before entering the study. Of 150 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen. Clinical and biochemical assessment was done at baseline and after 6 months. Serum High-sensitivity CRP (hsCRP), sortilin, Adiponectin and Leptin level was determined using ELISA Kit. Blood pressure (BP) and anthropometrical parameters, such as body-mass index (BMI) were calculated using the equation (BMI = weight (kg)/height (m2). Blood pressure was measured twice, after keeping participants in a sitting position for 15 min. The mean value of two consecutive measurements with 5 min intervals was used for study purposes. HbA1c% was determined by ion exchange method. Serum triglycerides (TGs), total cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) were determined colorimetrically. Low-density lipoprotein-cholesterol (LDL-C) was calculated according to Friedewald formula. Atherogenic Index (AI) is calculated through the following: Atherogenic Index = TCH/HDL-C as TCH/HDL-C ratio is an excellent CVD risk predictor and a good biomarker for deciding on the intensity and the need for therapeutic intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia Associated With Type II Diabetes Mellitus
Keywords
Adiponectin, Sortilin, Leptin, Dyslipidemia, Diabetes type II, Rosuvastatin, Atorvastatin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
160 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen.
Masking
ParticipantInvestigator
Masking Description
prospective, double blind trial
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrovastatin
Arm Type
Experimental
Arm Description
atorvastatin (40 mg per day) for 6 months
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
Rosuvastatin (10 mg per day) for 6 months
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40 Mg Oral Tablet
Other Intervention Name(s)
Atorvastatin 40mg tablet per day
Intervention Description
40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 10 Mg Oral Tablet
Other Intervention Name(s)
Resovastatin 10 mg daily
Intervention Description
10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months
Primary Outcome Measure Information:
Title
hs-CRP (pg/mL)
Description
biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.
Time Frame
6 months
Title
sortilin (ng/mL)
Description
Serum Level
Time Frame
6 months
Title
adiponectin (ng/mL)
Description
Serum Level
Time Frame
6 months
Title
leptin (ng/mL)
Description
Serum Level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
glucose level
Description
fasting blood glucose (FBG) (mg/mL)
Time Frame
6 months
Title
glycated hemoglobin
Description
glycated hemoglobin (Hb A1c%)
Time Frame
6 months
Title
total cholesterol
Description
TCH: total cholesterol (mg/dL)
Time Frame
6 months
Title
low density lipoprotein-cholesterol
Description
LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).
Time Frame
6 months
Title
high density lipoprotein-cholesterol
Description
HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).
Time Frame
6 months
Title
Triglycerides
Description
Triglycerides (mg/dL).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type II diabetic patients with hypercholesterolemia
Exclusion Criteria:
liver impairment,
renal insufficiency,
coronary artery disease,
metabolic disorders,
type I diabetes,
autoimmune diseases, cancer, infection,
use of anti-inflammatory drugs,
recent major surgery,
weight-loss or modified anti-hypertensive medications 12 weeks or less prior to enrolment,
ongoing or previous use of lipid-lowering medications (including other statins, fibric acid derivatives, nicotinic acid, cholestyramine, ezetimibe or omega-3 fatty acids) and contraindications to the use of statins.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab Werida, Lecturer
Organizational Affiliation
Damanhour University
Official's Role
Study Director
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24354929
Citation
Krysiak R, Zmuda W, Okopien B. The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia. Cardiovasc Ther. 2014 Apr;32(2):40-6. doi: 10.1111/1755-5922.12057.
Results Reference
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Type 2 Diabetic Patients Maintained on Statin Therapy
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